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OSAPhase 3ATTAIN-OSANCT06649045

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

A Phase 3 study testing Orforglipron in people with OSA and Overweight or Obesity, run by Eli Lilly and Company at 66 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
OSA, Overweight or Obesity
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
712 participants
Where
66 sitesin 9 countries
Study dates
22 Oct 2024to 30 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Master GZRA inclusion criteria
  • have AHI ≥15 on PSG as part of the trial at screening (V1).
  • have body mass index (BMI) ≥27 kg/m²
  • Study 1 GZ01 inclusion criteria
  • Participants who are unable or unwilling to use PAP therapy.
  • Participants must not have used PAP for at least 4 weeks prior to screening.
  • Study 2 GZ02 inclusion criteria
  • Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.

Who cannot join

  • Master GZRA exclusion criteria
  • Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
  • Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
  • Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
  • Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
  • Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
Show all 15Show fewer
  • Active device treatment of OSA other than PAP therapy
  • Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
  • Have a self-reported change in body weight >5 kg within 3 months prior to screening
  • Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
  • Have a prior or planned endoscopic and/or present device-based therapy for obesity.
  • Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
  • Study 2 GZ02 exclusion criteria
  • Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study.
  • Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.

Trial locations and contacts

66 sites in 9 countries.

66 sites in 9 countries

United States15 sites

  • The Sleep Spot - Maimonides

    Albuquerque, New Mexico, 87107

  • Care Access - Aurora

    Aurora, Colorado, 80012

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Prime Revival Research Institute, LLC

    Flower Mound, Texas, 75028

  • Ark Clinical Research

    Long Beach, California, 90815

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania, 15236

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Care Access - Shreveport

    Shreveport, Louisiana, 71105

  • EBGS Clinical Research Center

    Snellville, Georgia, 30078

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

China11 sites

  • Peking University People's Hospital

    Beijing, 100034

  • The First Hospital of Jilin University

    Changchun, 130021

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, 150001

  • Huzhou Central Hospital

    Huzhou, 313000

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, 471003

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006

  • Ningbo First Hospital

    Ningbo, 315010

  • Pudong New Area People's Hospital Shanghai

    Shanghai, 201200

  • ShenZhen People's Hospital

    Shenzhen, 518020

  • Wuxi People's Hospital

    Wuxi, 214023

Other trials in China

Argentina8 sites

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, C1405BUB

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC

  • Centro Privado de Medicina Respiratoria

    Paraná, 3100

  • Instituto Médico Río Cuarto

    Río Cuarto, X5800AEV

  • INECO Neurociencias Oroño

    Rosario, 2000

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, L6300

Other trials in Argentina

Germany8 sites

  • CIMS Studienzentrum Bamberg

    Bamberg, 96049

  • Advanced Sleep Research

    Berlin, 10117

  • InnoDiab Forschung Gmbh

    Essen, 45136

  • Unterfrintroper Hausarztzentrum Klinische Forschung

    Essen, 45359

  • Siteworks GmbH - Hannover

    Hanover, 30449

  • Siteworks - Karlsruhe

    Karlsruhe, 76137

  • Institut für Diabetesforschung GmbH Münster

    Münster, 48145

  • RED-Institut GmbH

    Oldenburg, 23758

Other trials in Germany

Mexico7 sites

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, 44130

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, 44670

  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, 21200

  • RM Pharma Specialists - Unidad Especializada en Datos

    Mexico City, 03100

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, 11650

  • CEINV Salud

    Monterrey, 64020

Other trials in Mexico

Brazil5 sites

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, 90430-001

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000

  • BR Trials - Ensaios Clinicos e Consultoria

    São Paulo, 01236030

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000

Other trials in Brazil

Japan5 sites

  • Kirigaokatsuda Hospital

    Kitakyushu, 802-0052

  • Osaka Kaisei Hospital

    Osaka, 532-0003

  • Sakai City Medical Center

    Sakai, 593-8304

  • Nakamura Clinic

    Urasoe, 901-2132

  • RESM Respiratory and Sleep Medical Care Clinic

    Yokohama, 222-0033

Other trials in Japan

Taiwan4 sites

  • Chiayi Christian Hospital

    Chiayi City, 600

  • China Medical University Hospital

    Taichung, 404332

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

Czechia3 sites

  • Nemocnice Rudolfa a Stefanie Benešov

    Benešov, 256 01

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900

  • Praglandia s.r.o

    Prague, 150 00

Other trials in Czechia

About this study

Official title: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.

Being tested
Orforglipron, Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT06649045
Study groupRoleWhat they receive
OrforglipronExperimentalParticipants will receive orforglipron orally. Study 1 GZ01: Participants who are unable or unwilling to use PAP Study 2 GZ02: Participants who plan to continue PAP therapy
Receives: Drug: Orforglipron
PlaceboPlacebo comparatorParticipants will receive placebo orally. Study 1 GZ01: Participants who are unable or unwilling to use PAP Study 2 GZ02: Participants who plan to continue PAP therapy
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Apnea-Hypopnea Index (AHI)

    Measured: Baseline to Week 52

Secondary outcomes (7)

  1. Percent Change from Baseline in AHI

    Measured: Baseline to Week 52

  2. Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)

    Measured: Baseline to Week 52

  3. Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-score

    Measured: Baseline to Week 52

  4. Percentage of Participants Achieving ≥50% AHI Reduction

    Measured: Baseline to Week 52

  5. Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10

    Measured: Baseline to Week 52

  6. Percent Change from Baseline in Body Weight

    Measured: Baseline to Week 52

  7. Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration

    Measured: Baseline to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start22 Oct 2024
  3. Primary completion21 Jul 2026
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06649045
Sponsor's protocol ID
27226
Other IDs
J5P-MC-GZRA, J5P-MC-GZ01, J5P-MC-GZ02
Acronym
ATTAIN-OSA
Status last verified
Sep 2026
First submitted
17 Oct 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Malhotra A, Gottlieb DJ, Kundel V, Woehrle H, Chakladar S, Firmino Goncalves L, Calamai G. Orforglipron for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight: Study design and baseline characteristics of ATTAIN-OSA, a phase 3 trial. Contemp Clin Trials Commun. 2026 Jun 19;52:101660. doi: 10.1016/j.conctc.2026.101660. eCollection 2026 Aug.

    PubMed 42383207

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with OSA and Overweight or Obesity, run by Eli Lilly and Company at 66 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, China, Argentina, Germany, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Apnea-Hypopnea Index (AHI) (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06649045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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